Illumina Launches TruSight™ Tumor Content Set

Enables Somatic Variant Detection in Solid Tumors Using Next-Generation Sequencing (NGS)

SAN DIEGO--(BUSINESS WIRE)--Apr. 4, 2013-- Illumina, Inc. (NASDAQ:ILMN) today announced the next product in its TruSight line of content sets, TruSight Tumor, for NGS-based somatic variant detection in solid tumors. TruSight Tumor provides optimized amplicon-based library preparation of 26 oncogenes and tumor suppressor genes selected for their involvement in common solid tumors, including lung, colon, melanoma, gastric, and ovarian cancer.

TruSight Tumor also offers a comprehensive NGS-based tumor profiling solution that provides a broader and more cost-effective view of tumor heterogeneity compared to genotyping-based methods. Researchers can simultaneously detect somatic changes in multiple genes across the tumor genome, as referenced in industry guidelines, as well as emerging biomarkers implicated in pharmaceutical clinical trials. Designed for use with formalin-fixed paraffin-embedded (FFPE) samples, TruSight Tumor enables high levels of sensitivity for minor allele detection (below 5%), with limited DNA input requirements.

“TruSight Tumor is designed to run on Illumina’s industry-leading sequencing platforms and enables clinical researchers to understand the molecular heterogeneity of FFPE tumor samples,” said Matt Posard, Senior Vice President and General Manager of Illumina’s Translational and Consumer Genomics business. “This technology has the potential to expand candidates for targeted therapies who may otherwise be missed with single variant or single gene approaches.”

“Tumor characterization using next-generation sequencing enables clinical research laboratories to gain a deeper understanding of underlying biology. In order to detect clinically relevant variants, it is important to look beyond single genes or hotspot mutations while achieving very low levels of sensitivity," said Dr. Robert Daber, Technical Director of Clinical Genomics, Center for Personalized Diagnostics, Department of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania.

TruSight Tumor is the first content set designed for somatic variant detection on the Illumina MiSeq® platform. As a portfolio, TruSight content sets are designed for high performance targeted sequencing to meet the specific needs of the clinical research laboratory by providing high analytical sensitivity and specificity. They offer exceptional performance in the capture and sequencing of targeted genomic regions, and are selected through collaborations with experts from leading institutions.

TruSight content sets are for research use only and not intended for diagnostic use. TruSight Tumor is now available for order with shipment expected in Q2’13. For more information, visit www.illumina.com/TruSightTumor.

About Illumina

Illumina (http://www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paving the way for molecular medicine and ultimately transforming healthcare.

Forward-Looking Statements

This release contains forward looking statements that involve risks and uncertainties. Examples of forward-looking statements include, but are not limited to, statements we make regarding the expected shipping date for TruSight Tumor. Important factors that could cause actual results to differ materially from those in any forward-looking statements include challenges inherent in developing, manufacturing, and launching new products and services and the other factors that are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.

Source: Illumina, Inc.

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